LIST OF DRUGS DURING 2004 S.NO Name Of Drug Pharmacological Classification Date of Approval 188 Dutasteride For BPH 16-02-2004 189 Gefitinib Anti-cancer 17-02-2004 190 Imidapril Anti-hypertensive 23-02-2004 191 Adefovir Dipivoxil Anti-Viral (Hepatitis-B) 4/3/2004 192 Etoricoxib NSAID 5/3/2004 193 Diacerein For Osteoarthritis 12/3/2004 194 Nitazoxanide Anti-Diarrhoeal 17-03-2004 195 Trolamine Cream (0.67%) For Topical use 20-03-2004 196 Neotame Sweetening Agent 22-04-2004 197 Oxybutynine E.R. tablets For Neurogenic bladder disorder 5/5/2004 198 Cabergoline 1 mg/2 mg/4 mg tablets For Parkinson s disease 7/5/2004 199 Rabeprazole Sodium Injection For Gastric and Deudonal Ulcers & GERD 20 12/5/2004 200 Alfuzosin E.R. Tablets (10 mg) For BPH 14-05-2004 201 Tiagabine HCl tablet Anti-Epileptic 14-05-2004 (2/ 4 /12 /16 mg) 202 Racecadotril Sachet (10 mg/30 mg) Anti-diarrhoeal 18-05-2004 203 Ibandronic Acid Inj ( 1 mg/ml) For Anti-Cancer 18-05-2004 204 TacrolimusCapsule For organ rejection 21-05-2004 5 mg) (0.5mg/1mg/ 205 Cefdinir Dispersible tablet (125mg) Anti-biotic 27-05-2004 206 Linezolid (600 mg) Tablet For Osteomyelitis in adults 30-05-2004 207 FDC of Gatifloxacin 0.3% + Dexamethasone Phos. 0.1% w/w Eye drops 208 Cefprozil Dispersible Tablet (125 mg/ 250 mg) 209 Divalproex Sodium E.R. Tablets (750mg/1000 mg) For post-operative inflammatory and bacterial infection of eyes. 15-06-2004 Anti-biotic 22-06-2004 Anti-Epileptic 24-06-2004
210 Lithium Carbonate ER (450mg) tablet Anti-Depression 28-06-2004 211 Nimesulide Injection 75mg/ml. For short-term treatment of postoperative pain. 212 FDC of Esomeprazole 20 mg/40 mg + Domperidone 30 mg SR Capsule 213 Aceclofenac (100 mg) + Paracetamol(500 mg) 214 FDC of Lamivudine 300 mg (E.R) + Zidovudine 600 mg (E.R) + Nevirapine 400 mg tablets 215. Levosalbutamol Tablet 1 mg/2mg & Syrup 1 mg/5 ml. 28-06-2004 For GERD 29-06-2004. For acute painful condition in adults 29-06-2004 Anti-AIDS 15-07-2004 For Obstructive airway disease 16-07-2004 216 Memantine HCl tablet 5 mg/10 mg. For dementia of Alzheimer s type 19-07-2004 217 Pimcrolimus 10 mg/gm cream For atopic dermatitis 23-07-2004 218 FDC of Rabeprazole (20 mg) + Mosapride S.R. (15 mg) Tablet For GERD 27-07-2004 219 Rebamipide 100 mg tablet For gastric ulcer 28-07-2004 220 Cefetamet Pivoxil Suspension 250 mg/5ml Anti-biotic 9/8/2004 221 Diclofenac Transdermal patch For Osteoarthritis & soft tissue 100 mg/50 Cm 2 injury 10/8/2004 222. Fluconazole Gel (0.5%) Anti-fungal 12/8/2004 223. FDC of Atorvastatin (10 mg/20 mg) + Ezetimibe (10 mg) Table 224. Miglitol Tablet 25 mg/50 mg/100 mg 225 FDC of Buprenorphin 2 mg + Naloxone (0.5 mg) 226 FDC of Sucralfate 0.07 + metronidazole 0.01 gm + Lignocain 0.04 gm per gram of cream 227 Citicholine Tablet 500 mg & Injection 250 mg/ml 228 FDC of Glibenclamide 2.5 mg/ 5 mg + Metformin SR 500 mg tablet 229 Lamotrigine S.R. tablet 50 mg/100 mg/200 mg 230 Moxifloxacin Eye drops (0.5%) For Hypercholesterolemia 13-08-2004 Anti-Diabetic 18-08-2004 For Opiod Dependency 19-08-2004 For bedsore, haemorrhoid fistula and anal fussure Membrane permeability enhancer 19-08-2004 20-08-2004 Anti-diabetic 20-08-2004 Anti-Epileptic 26-08-2004 For bacterial conjunctivitis 26-08-2004
231 Risperidone long-acting suspension for injection 25 mg/37.5 mg/50 mg per vial For Schizophrenia 26-08-2004 232 Escitalopram (10mg) + Clonazepam (0.5mg) 234 Everolimus Tablets (0.25 mg/ 0.5 mg/0.75 mg/1.0 mg) For co-morbid depression & anxiety disorder. 27-08-2004 Immunosuppressant 30-08-2004 235 Dorzolamide (20 mg) + For reduction of elevated IOP. 1/9/2004 Timolol (5 mg) per ml Eye drops 236 Gemcitabine (1.4 gm/vial) Anti-cancer 1/9/2004 237 b -arteether Injection Anti-malaria 1/9/2004 (150 mg/2 ml) 238 Ziprasidone powder for injection (after reconstitution 20 mg/ml) 239 Voriconazole Tablet (50 mg/200 mg) Infusion (200 mg/vial) 240 FDC of Nebivolol (5 mg) + S(-) Amlodipine (2.5 mg ) tablet Anti-psychotic 3/9/2004 Anti-fungal 9/9/2004 Anti-hypertensive 14-09-2004 241 FDC of Valdecoxib (20 mg) + Paracetamol (500 mg) tablet For pain relief in adults. 20-09-2004 242 Amlodipine (5 mg) + Anti-hypertensive 24-09-2004 Ramipril (2.5 mg) tablet 243 FDC of Rabeprazole Sodium (20 mg) + Domperidone(30 mg) S.R Capsule 244 Cefuroxime Axetil ER tablets (500 mg/1000mg) For GERD 4/10/2004 Anti-biotic 6/10/2004 245 Diclofenac Transdermal Patch For pain relief. 6/10/2004 (200 mg/75 cm 2 ) 246 Gatifloxacin Eye Ointment (1%) 247 Nimesulide Injection (100 mg/ml) (Veterinary) Ophthalmic use 6/10/2004 Veterinary use 8/10/2004
248 Isotretinoin Gel (0.05%) For acne 11/10/2004 249 FDC of Epi-Growth Factor (1 gm) + Silversulphadiazine Cream For Burns 19-10-2004 250 FDC of Amlodipine (5mg/10 mg) + Atorvastatin (10/20/40 mg) For co-existing hypertension & hyperlipidemia 20-10-2004 251 Levosalbutamol rotacaps (100 mcg/capsule) & inhaler For obstructive airway disease. 20-10-2004 (50 mcg /actuation) 252 Celecoxib Injection (100 mg/ml) For acute pain 28-10-2004 253 Orlistat (120 mg) Capsule Anti-obesity 27-10-2004 254 Duloxetine HCl (20,30,40mg) Tablet Anti-depressant 2/11/2004 255 Deflazacort (1,6,30mg) tablet Anti-asthma, anti-arthritis. 2/11/2004 256 Atomoxetine HCl (10,18, 25 & 40mg ) capsule 257 Ursodeoxycholic acid S.R. Capsule (450mg) 258 Methylphenidate HCl (18, 36, 54 mg) E.R. tablet 259 FDC of Lovastatin (20mg) + Nicacin ER (500mg) tablet 260 FDC of Gatifloxacin (400mg) + Ambroxol HCl (75mg) tablet For ADHD 9/11/2004 For dissolution of gall stones 1/12/2004 For ADHD 8/12/2004 For Lipid-lowering 20-12-2004 RTI in adults. 21-12-2004 261 FDC of Nebivolol HCl (5mg) + Hydrochlorothiazide (12.5mg) tablet Anti-hypertensive 22-12-2004 262 FDC of Atorvastatin Calcium (10mg) + Finofibrate (160mg) tablet For hyperlipidemia 22-12-2004 263 Calcium Polycarbophil (500mg) tablet 264 Pantoprazole (40mg) + Domperidone (20mg) ( 10mg IR + 10mg SR) For constipation 23-12-2004 GERD 23-12-2004 265 Imiquimod Cream 5% w/w For warts in adults 28-12-2004
266 Entacapone (200mg) tablet For Parkinson s disease 30-12-2004